Organization

Profiles

Our Management is a true combination of leadership, talent, scientific knowledge, and ability to work as a team. An interdisciplinary group of people with a history of success, enriched over time by newcomers with a proven track record who have fuelled the Company with enthusiasm and experience.

Lucio Rovati, MDChief Executive Officer - Chief Scientific Officer

Lucio Rovati joined the Company in 1988, following the footsteps of his father, Professor Luigi Rovati who was the founder of the Rottapharm Group.

After graduation in Medicine and Postgraduate specialization in Clinical Pharmacology at the University of Milan, he completed his training as attending physician in Internal Medicine and served as research fellow in the Department of Medical Pharmacology, Chemotherapy and Toxicology of the University of Milan, School of Medicine, for four years.

In Rottapharm, he served as head of Clinical Pharmacology and Clinical Research before becoming Chief Scientific Officer, directing all R&D activities of the Group, and Executive Medical Director responsible for all international medical activities of the Company and its subsidiaries. He founded Rottapharm Biotech in 2014 and currently is Chief Executive Officer and Chief Scientific Officer of the Company.

Besides his experience in internal medicine, Lucio has laboratory skills on in vitro and in vivo pharmacology, particularly of the musculoskeletal, digestive and central nervous systems. However, his most relevant expertise derives from his wide clinical research activity in the direction (including planning, performance and reporting) of clinical research programs and studies for the development of new drugs in rheumatology, gastroenterology/hepatology, gynaecology, bronchopneumology, neurology/psychiatry, cardiology, metabolism and internal medicine.

After holding similar positions at the Universities of Naples and of Parma, Dr Rovati is at present and since 2003 Invited Professor of Clinical Pharmacology at the University of Milano-Bicocca, School of Medicine, where he is also Coordinator of a Postgraduate Master in Pharmaceutical Medicine.

Dr Rovati is an active member of several international scientific societies in different disciplines, where he is also included in panels providing advice to the Food and Drug Administration or the European Medicine Agency on the drafting of drug development guidelines.

Finally, he is the author of over 175 full papers in peer reviewed international scientific journals (H-index=42), 15 book chapters and over 400 abstracts. Dr Rovati has been among the ten Italian scientists with the largest number of publications in clinical research.

Giovanna Forlanelli, MDGeneral Manager

Michela Visintin, PhDBiotherapeutics Discovery - Director

The Biotherapeutics Discovery team provides Rottapharm Biotech with a strong expertise in protein and antibody engineering, antibody discovery for improved therapeutic application, and protein assay development. This research requires a highly interdisciplinary approach, combining detailed biophysical studies, computer modelling and advanced molecular biology. As such, many projects involve a close collaboration with renowned academic research groups in the field of crystallography and NMR spectroscopy.
Several large antibody libraries (Single Pot Library of Intrabodies – SPLINT) have been generated by the group. These libraries are screened to select, by means of a proprietary technology platform (Intracellular Antibody Capture Technology – IACT), panels of antibodies for unmet medical needs.
Michela Visintin joined the Company in 2008 and currently serves as Biotherapeutics Discovery Director.
Michela holds a Science Biology degree from the University of Trieste and a PhD in Biophysics from the International School for Advanced Studies in Trieste.
Prior to joining Rottapharm Biotech, she was head of the Antibody Technology Unit at Lay Line Genomics, a spin-off of the International School for Advanced Studies (SISSA) with the mission to discover and develop innovative biopharmaceuticals for the treatment of neurological diseases. During her PhD and later on in Lay Line Genomics, she worked on selection methods for isolating intracellular antibodies (intrabodies) and related methods for disease target validation and discovery of innovative biotherapeutics. All these technologies have been industrially exploited in Rottapharm Biotech. She also co-authored several scientific papers and patents in the field of biotechnology and protein knock-out technology.
In Rottapharm Biotech she is responsible for the discovery of novel biotherapeutics. Thanks to over 15 years of experience in biotechnology development and protein engineering, Michela played a key role in establishing the first Rottapharm Biotech’s antibody lead discovery capability.

Roberto Artusi, MChemMedicinal Chemistry - Director

Medicinal Chemistry at Rottapharm Biotech takes advantage of scientists with a well-established experience in synthetic and computational chemistry for the design of innovative new chemical entities. The synthesis capability is well suited to reach the multigram scale, in order to meet in vitro and in vivo preclinical testing needs.

Medicinal Chemistry programs take also advantage of the possibility to access a high-throughput screening library for fast identification of hit compounds on different targets.

Roberto Artusi holds a degree in Chemistry from the University of Milan. He joined the Company in 1997 as a synthetic chemist and, since then, has been approaching various aspects of medicinal chemistry and project management. Through the years, Roberto has played a pivotal role in developing and implementing the processes that now, at Rottapharm Biotech, are used to streamline the transition of original molecules from discovery to preclinical development. He has been involved in many projects on different areas, particularly in rheumatic diseases (osteoarthritis, rheumatoid arthritis) and CNS diseases (sleep disorders, drug addiction). Currently, Roberto serves as Director of Medicinal Chemistry, coordinating the activities of two analytical and two chemistry labs, a computational group, and other outsourced chemical activities.

Gianfranco Caselli, PhDPharmacology and Toxicology - Director

Rottapharm Biotech’s Pharmacology and Toxicology comprises more than 30 scientists who work in state-of-the-art laboratories extending over a surface area of more than 2000 m2. Rheumatic diseases and pain therapy are the main areas of expertise, with an outstanding array of models developed and available in-house. Other areas of expertise include the gastrointestinal system, the CNS, and the respiratory system.

The group is engaged throughout the whole R&D process, from discovery to preclinical development of new drugs (both small molecules and biologics). On the one hand, it deals with the pharmacological characterisation of new drug candidates, from screening to the definition of in-depth mode of action. On the other hand, it deals with their toxicological profile definition: early and regulatory toxicology up to the first administration to humans (mutagenesis, safety pharmacology and subacute toxicology), or to the market authorization (chronic toxicology, reprotoxicology, carcinogenesis).

Gianfranco Caselli joined the Company in 2001 and currently serves as Pharmacology and Toxicology Director. Gianfranco Caselli holds a degree in Pharmaceutical Chemistry and Technology from the University of Milan, where he also completed his post-doctoral training in Pharmacognosy at the Institute of Pharmacology, School of Pharmacy, and specialized in Toxicology. Gianfranco started his career as Manager of the Laboratory of Nutritional Biochemistry at Pierrel, and then moved to Dompé where he worked for fifteen years, covering different management roles up to the direction of Pharmacology and Toxicology.

Antonio Giordani, PhDChemistry Drug Development - Director

With an in-depth experience in Active Pharmaceutical Ingredient (API) Process Research & Manufacturing, Antonio Giordani spent more than 20 years in managing Drug Development projects in the Pharmaceutical Industry.

Antonio Giordani graduated in Organic Chemistry at the University of Pavia and then specialized in Stereospecific Synthesis at the Politecnico University of Milan. After working as medicinal chemist in major pharmaceutical companies such as Beecham and Farmitalia Carlo Erba, he joined the API group of Pharmacia Co. in 1997, formerly as Director of Process Development Labs and later as Project Leader within API Global Supply & Technology Management Group, where he coordinated the development of several drugs, mainly in CNS and oncology areas. In 2003 he joined Rottapharm, where he coordinated medicinal chemistry, analytical, and process development activities. In 2008 his work focused on Drug Development activities, including Process and Analytical Development and Solid State issues. He has had responsibilities for Chemistry Manufacturing and Controls (CMC) activities up to the present.

In addition to process research and manufacturing competencies, Antonio also has an in-depth knowledge of the chemical-physical approaches aimed at controlling polymorphism, physical form and mechanical properties of pharmaceutical products, as well as knowledge and competence in analytical chemistry and its use for an appropriate support to quality programs. A significant experience in establishing and managing appropriate CRO/CMO networks completes Antonio’s skills.

Matteo Ghirri, PharmDPharmaceutical Development - Director

At Rottapharm Biotech, Pharmaceutical Development has been structured to provide a blend of strong conceptual and technological skills. As such, the group is involved in many interdisciplinary activities such as development of Galenical, Analytical and Manufacturing Processes; management of Investigational Medicinal Product supplies for clinical trials; and outsourcing of Pharmaceutical Development activities, including selection and evaluation of CROs, CMOs, and other vendors involved.

Matteo Ghirri joined the Company in 1998 and currently serves as Pharmaceutical Development Director.

Matteo holds a degree in Pharmaceutical Chemistry and Technology from the University of Milan. Prior to joining Rottapharm he had gained significant experience in standard and controlled-/modified-release formulation methodologies, as well as in process development. At Rottapharm he extended his expertise to the development of a wide range of pharmaceutical products including transdermal delivery systems, injectable products, and medical devices. He supported many industrial operations of scale-up or manufacturing site relocation of pharmaceutical as well as dermo-cosmetic and nutraceutical products. He also acquired the expertise for the development of drug products for clinical trials. In 2005 he was responsible of the activation of the Rottapharm’s Investigational Medicinal Products packaging unit.

The Translational Sciences and Pharmacokinetics team has the know-how and experience to support drug discovery, lead optimization, formulation, preclinical and clinical development, as well as regulatory activities, across all therapeutic areas for small molecules, biological products, and medical devices. Internal state of the art laboratories and animal facilities have been built and strategically organized to rapidly generate in vitro, in vivo, and clinical data that are crucial to streamline the R&D processes.

Stefano Persiani joined the Company in 2000 and currently serves as Director of Translational Sciences and Pharmacokinetics.

After his Pharmacy degree from the University of Milan, and after a one-year scholarship at the National Cancer Institute of Milan, he obtained a Postdoctoral Fellowship from the University of Pittsburgh, School of Medicine, at the Pittsburgh Cancer Institute. He progressed through academia as Research Associate in the Department of Pharmaceutics, University of Southern California, School of Pharmacy, Los Angeles, conducting both teaching and research activities. In 1990 he left the academia holding different managerial positions in drug R&D at Farmitalia Carlo Erba, Pharmacia, Upjon, and Zambon and as Scientific Director in clinical pharmacology CROs until joining Rottapharm in his current role. His experience spans throughout drug R&D in oncology, anti-infective, cardiovascular, respiratory, CNS, gastrointestinal, and rheumatology. He holds memberships in several international scientific societies and acts as an independent expert evaluator for the European Commission Seventh Framework Program and Innovative Medicine Initiative. He teaches and consults in drug development and is an author of more than 100 publications.

Massimo D’Amato, MDClinical Research - Medical Director

Thanks to the experience gained in the management of an R&D pipeline and a portfolio of marketed products, Rottapharm Biotech’s Clinical Research is much more than a unit that oversees clinical development activities across different therapeutic areas for small molecules, biological products, and medical devices. It is empowered and knows how to create value through the conduct of state-of-the-art and innovative clinical studies in collaboration with highly specialised hospital, research and teaching centres of excellence.

Massimo D’Amato joined the Company in 1992 and currently serves as Clinical Research Medical Director.

He holds a degree in Medicine and a Postgraduate degree in Gastroenterology, both from the Catholic University of the Sacred Heart of Rome, where he spent several years after his graduation.

During his academic career, Massimo completed a one-year Belgium Government Fellowship at the Heymans Institute of Pharmacology, Ghent Medical School, and a two-year British Council Fellowship at The Rayne Institute, King’s College School of Medicine & Dentistry, London. Thereafter, he served for 3 years as Scientific Director of a Research Programme funded by the Italian National Research Council. As a researcher in the academia he engaged in basic science and clinical research activities in collaboration with leading international groups, focusing on the physiology and pharmacology of the gastrointestinal tract. He also started being involved in teaching activities that continue to date.

His recognized expertise in clinical research and drug development, which spans from gastroenterology to hepatology, lipid and glucose metabolism, rheumatology, bronchopneumology and CNS, led to his inclusion in international expert groups of scientists from the academia, pharmaceutical industries and EMA, acting as consultant to the CHMP. He holds memberships in several international scientific societies and is author or co-author of more than 200 publications.

Giampaolo Giacovelli, PhDBiostatistics - Director

A group of experts in different knowledge management disciplines, the Biostatistics team provides Rottapharm Biotech with strategic advice and guidance on the conception of clinical development plans, design of innovative clinical trials, selection of clinical endpoints, analysis and interpretation of clinical trial results, and development of new clinical hypotheses to be explored.

Giampaolo Giacovelli joined the Company in 1987 and currently serves in Rottapharm Biotech as Director, Biostatistics, with responsibility on biostatistics, data management and bioinformatics.

Giampaolo Giacovelli holds a degree in Biological Sciences from the University of Milan and a Diploma in Medical Physics and Radioisotopic Techniques from the Politecnico University of Milan. In nearly 30 years of career in the pharmaceutical industry, he held different positions of rising responsibility and matured a wide experience in drug development, mainly in the clinical phases. Thanks to a deep involvement in the design and conduct of multiple preclinical/clinical international projects, he has gained extensive expertise in several therapeutic areas such as gastroenterology, gynaecology, bronchopneumology, hepatology, and rheumatology.

His expertise includes, among others, the development of innovative drugs in the fields of irritable bowel syndrome (IBS), hormone replacement therapy, contraception, asthma, hepatitis C, analgesia, osteoporosis and especially osteoarthritis. Indeed, Giampaolo has gained an international reputation as a clinical trial methodologist in osteoarthritis.

Francesca Fanti, PharmDRegulatory and Quality Affairs - Director

Francesca Fanti joined the Company in 2010 and currently serves as Regulatory and Quality Affairs Director. At Rottapharm Biotech she is responsible for Regulatory Affairs activities and strategy within the Company, in order to expedite approval of regulatory applications supporting clinical trials and to address specific questions from Regulatory Authorities. She is also responsible for managing and coordinating Quality Control outsourced activities (e.g. stability studies, analytical methods set up and validation, development investigations) through appropriate personnel and liaison with technical functions, including consultants/vendors qualification and appropriate Standard Operating Procedure set up.

Francesca Fanti holds a Pharmaceutical Chemistry and Technology degree from the University of Bologna. Prior to joining Rottapharm, she spent almost 20 years at GlaxoSmithKline where she developed her career and gained a deep understanding of the pharmaceutical and biotechnology industry. Initially she was in charge of quality aspects and organization of the Departments in terms of GMP, GLP, Standard Operating Procedures (SOPs), training, and audits. In 2001 she became part of the Global Regulatory Affairs CMC (Chemistry, Manufacturing and Controls) Pre-Approval Department based in UK/US. In this role she coordinated, prepared and delivered the CMC components of global regulatory applications for new chemical entities and product line extensions from First-in-Humans studies to global marketing approval, including regulatory strategy for new drug substances and drug products delivery and supply, and led Global Regulatory Affairs teams based in Europe and North America.

Federica Girolami joined the Company in 2006 and currently serves as Business Development, Scientific Liaison and Drug Safety Director. In Rottapharm Biotech she provides strategic support to the Chief Executive Officer in negotiations and strategic alliances networking to attract external partners. She is responsible for in-licensing, out-licensing and partnering activities, and for identifying opportunities for Rottapharm Biotech’s assets across all therapeutic areas. In her role of Scientific Liaison, she is responsible for cultivating and maintaining relationships with academic researchers and key opinion leaders, acting as a bridge of communication for both external and internal stakeholders.

Additionally, given her long-standing experience in Pharmacovigilance and Drug Safety, she is responsible for all Drug Safety activities in Rottapharm Biotech’s Clinical Trials.

Federica Girolami holds a Pharmacy degree from the University of Florence and a Master degree in International Health Care Management, Economies and Policy from the SDA Bocconi School of Management in Milan. Prior to joining Rottapharm, she had gained significant experience in the international arena, with roles of increasing responsibility in multinational pharmaceutical companies in Europe. After starting her career at Du Pont Pharma in Florence, she joined the Swiss headquarters of Helsinn Healthcare, where she contributed to one of the first EMA safety referrals and authored the first pharmacoeconomic publication of a new antiemetic drug in oncology. Very early in her career, she took the responsibility of creating the company Pharmacovigilance and Drug Safety function at IBSA, eventually becoming European Qualified Person responsible for Pharmacovigilance (QPPV) for the group.

In the former Rottapharm|Madaus Group she served as Director Corporate Pharmacovigilance and Drug Safety Department and Deputy QPPV for 8 years coordinating the function globally. In 2015, she was advanced to her current role to provide strategic support to Rottapharm Biotech’s Chief Executive Officer.